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Baxter's February 2005 Corrective Action for COLLEAGUE Infusion Pump Receives FDA Class I Designation

Sep 21, 2005 | PRNewswire

Baxter Healthcare Corporation announced that it was notified this week by the U.S. Food and Drug Administration (FDA) that the FDA has classified a February 25, 2005 voluntary notice from Baxter to customers regarding the company's COLLEAGUE Volumetric Infusion Pump as a Class I recall.

All COLLEAGUE infusion pump models are affected. This classification does not require the return of infusion pumps currently in the market. Baxter has advised health care institutions to have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

Specifically, there have been reports of damage to the pump's batteries, including swelling and excessive discharge. Both of these issues will result in irreversible damage to the battery. If either one of these situations occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of life-sustaining therapy and the possible death or serious injury of patients. To date, Baxter has received reports from customers of battery damage due to excessive discharge, which may have been associated with four deaths and ten serious injuries.

Normally, a properly maintained battery will provide approximately 30 minutes of remaining infusion time during a "battery low" alert. This is then followed by a "battery depleted" alarm that will stop the infusion of therapy and trigger an audible tone. However, for a pump with a damaged battery, the time frame between a "battery low" alert and a "battery depleted" alarm can be much shorter. It is also important to note that when the batteries become excessively discharged, the battery charge level indicator may overstate the amount of battery charge remaining.

In the Important Product Information Letter dated February 25, 2005, Baxter notified its users of the actions they can take to minimize the occurrence of these device failures, including following proper battery maintenance procedures. The company informed users that a modified battery harness could be installed in the pumps to help prevent the batteries from swelling. The letter also stated that future software updates would help address the issue of battery damage due to excessive discharge.

Earlier this year, Baxter announced that the company would voluntarily hold shipments of new pumps until issues are resolved. Baxter continues to address this issue as part of its remediation efforts previously communicated on July 21, 2005. The company does not expect any additional charges to cover costs associated with these issues.

Approximately 256,000 COLLEAGUE infusion pumps are currently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected.


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